A Multi-center, Randomized, Double-Blind Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a randomized double-blind placebo-controlled phase 3 clinical trial to further validate the effectiveness and safety of Shugan Jieyu Capsules in treating generalized anxiety disorder.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• Primary diagnosis of generalized anxiety disorder (GAD) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) as confirmed by the MINI at Screening, The duration of illness must be ≥ 6 months；
• Age 18-65 years old；
• Hamilton Anxiety Rating Scale (HAM-A) Total Score of ≥ 14 at both Screening and Baseline，Anxious Mood (item 1) score ≥2；
• Clinical Global Impression of Severity Scale (CGI-S) score of ≥ 3 at both Screening and Baseline
• The TCM syndrome is liver Qi stagnation and spleen deficiency syndrome.
Locations
Other Locations
China
Beijing Anding Hospital Affiliated to Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Ling Song
022516@cnkh.com
028-81258178
Time Frame
Start Date: 2023-04-17
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 495
Treatments
Experimental: Experimental: Shugan Jieyu Capsules
Participants received Shugan Jieyu Capsules 4 capsules,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 weeks.
Placebo_comparator: Experimental: Shugan Jieyu Capsules Placepo
Participants received Shugan Jieyu Capsules Placebo 4 capsules,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 weeks.
Related Therapeutic Areas
Sponsors
Leads: Sichuan Jishengtang Pharmaceutical Co., Ltd.